- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02497248
Non-invasive Characterization of the Mechanisms of Atrial Fibrillation Maintenance (PERSONALIZE)
PERSONALIZE-AF: Non-invasive Characterization of the Mechanisms of Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The MAIN GOAL of this project is to clinically validate the technology for the noninvasive identification of the mechanisms responsible for maintenance of AF by body surface electrical mapping. To achieve this goal, noninvasive mapping of the atrial activity will be correlated with simultaneous endocardial mapping (high density contact catheters) using advanced signal analyses techniques (Dominant frequency, phase and causality mapping, inverse solution problem). These analyses will be performed in patients with different mechanisms of maintenance of AF (e.g. paroxysmal, persistent, valvular) undergoing AF ablation for clinical indication. Both endocardial and body surface mapping results will be correlated with biomarkers levels, MRI scans and AF outcomes of AF ablation at 6 months and 1 year after the procedure.
Wide antrum circumferential pulmonary vein isolation with demonstration of bidirectional block will be performed using standard cooled-tip radiofrequency catheters. In patients with mitral stenosis, PBMV will be performed according to Inoue´s technique followed by wide antrum circumferential pulmonary vein isolation. In all patients, MRI/CT scans and fibrosis biomarkers will be obtained at baseline, 6 months and 1 year post ablation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain, 28007
- Felipe Atienza Fernandez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication.
- Patients with persistent AF symptomatic and refractory to at least one antiarrhythmic medication.
- Patients with severe mitral stenosis (mitral valve area ≤1.5 cm2, stage D) and favorable valve morphology in the absence of left atrial thrombus or moderate-to-severe mitral regurgitation.
- Patients must be able and willing to provide written informed consent to participate in the study.
- Prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi (in patients with paroxysmal AF).
Exclusion Criteria:
- Patients with inadequate anticoagulation levels.
- Patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
- Patients with moderate-to-severe mitral regurgitation.
- Patients with contraindications to systemic anticoagulation with heparin or coumadin.
- Prior atrial fibrillation ablation.
- Patients who are or may potentially be pregnant.
- Contraindication for adenosine administration;
- Current enrollment in another investigational drug or device study.
- Pacemaker or Implantable Cardioverter Defibrillator.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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- Patients with paroxysmal AF.
Patients with AF episodes that terminates spontaneously or with intervention in less than seven days with clinical indication of pulmonary vein ablation.
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Simultaneous biatrial endocardial electroanatomical mapping by high-density basket catheter (64 pin) and customized body surface mapping (57 electrodes) followed by circumferential pulmonary vein ablation.
Other Names:
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- Patients with persistent AF.
Patients with AF episodes that fails to self-terminate within seven days or require pharmacologic or electrical cardioversion to restore sinus rhythm with clinical indication of pulmonary vein ablation..
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Simultaneous biatrial endocardial electroanatomical mapping by high-density basket catheter (64 pin) and customized body surface mapping (57 electrodes) followed by circumferential pulmonary vein ablation.
Other Names:
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- Patients with mitral stenosis.
- Patients with mitral stenosis and clinical indication for AF ablation undergoing percutaneous balloon mitral valvuloplasty (PBMV) with clinical indication of pulmonary vein ablation..
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Simultaneous biatrial endocardial electroanatomical mapping by high-density basket catheter (64 pin) and customized body surface mapping (57 electrodes) followed by circumferential pulmonary vein ablation.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF.
Time Frame: 12 months post-first ablation procedure
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12 months post-first ablation procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Freedom from atrial fibrillation on or off antiarrhythmic medication post-first ablation procedure and after redo procedures.
Time Frame: at 6 and 12 months
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at 6 and 12 months
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Freedom from atrial fibrillation and other atrial arrhythmias post-first ablation procedure and after redo procedures.
Time Frame: at 6 and 12 months
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at 6 and 12 months
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Incidence of peri-procedural complications
Time Frame: during ablation procedure and 12 months after
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during ablation procedure and 12 months after
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Procedure duration
Time Frame: Duration of ablation procedure, and valvuloplasty if indicated, in minutes
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Duration of ablation procedure, and valvuloplasty if indicated, in minutes
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Body surface recording analysis by 120 disposable electrodes distributed over the patient's chest and connected to the polygraph.
Time Frame: During ablation procedure, and valvuloplasty if indicated
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During ablation procedure, and valvuloplasty if indicated
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Electroanatomic reconstruction and recordings of electrical activity: a three-dimensional reconstruction of atrium and coronary sinus is obtained using high density catheters and an electroanatomic navigation system.
Time Frame: During ablation procedure, and valvuloplasty if indicated
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During ablation procedure, and valvuloplasty if indicated
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Atrial fibrosis determination using late gadolinium enhancement-MRI
Time Frame: At 6 and 12 months
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At 6 and 12 months
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Fluoroscopy time
Time Frame: During ablation procedure, and valvuloplasty if indicated, in minutes
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During ablation procedure, and valvuloplasty if indicated, in minutes
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Collaborators and Investigators
Investigators
- Principal Investigator: Felipe Atienza, MD, Red de Investigación Cardiovascular
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PERSONALIZE-AF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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